In Vitro Dissolution Testing: Statistical Approaches and Issues
作者： David LeBlond
DOI: 10.1007/978-3-319-23558-5_23
关键词:
摘要: Dissolution (or in vitro release) studies play an important role during pharmaceutical drug development. They are useful as a quality control tool, establishing IVIVC, justifying biowaiver and supporting equivalence between generics innovator products. This chapter provides overview of regulatory guidances related to dissolution testing. The question profile comparisons the challenges defining similarity discussed. limitations f 2 statistic, driven test, described, with emphasis on lack statistical basis for test. strengths weaknesses alternative approaches described. A Bayesian test procedure is given that mitigates large extent other by providing coherent connection parameter “fit use” probability statement similarity.
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